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Devices
Device Recall Active Electrode Monitoring System
Model / Serial
Catalog number EM2+A NC, all serial numbers.
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
No
Distribution
CA, IL, KS, OH, OK, PA, TN. No government or military accounts. Foreign distribution to Canada and Italy.
Product Description
EM2+A NC AEM Monotor (NON-COM)
Manufacturer
Encision, Inc.
1 Event
Recall of Device Recall Active Electrode Monitoring System
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Manufacturer
Encision, Inc.
Manufacturer Address
Encision, Inc., 4828 Sterling Drive, Boulder CO 80301
Source
USFDA
2 devices with a similar name
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Device Recall Active Electrode Monitoring System
Model / Serial
Catalog Number EM2 NC, all serial numbers.
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
No
Distribution
CA, IL, KS, OH, OK, PA, TN. No government or military accounts. Foreign distribution to Canada and Italy.
Product Description
EM2 NC AEM Monitor (NON-COM)
Manufacturer
Encision, Inc.
Device Recall Active Electrode Monitoring System
Model / Serial
Catalog number EM2M NC, all serial numbers
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
No
Distribution
CA, IL, KS, OH, OK, PA, TN. No government or military accounts. Foreign distribution to Canada and Italy.
Product Description
EM2M NC AEM Monitor, (NON-COM)
Manufacturer
Encision, Inc.
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